(41 days)
Not Found
No
The document describes a standard fiberscope and does not mention any AI/ML terms, image processing capabilities beyond basic visualization, or performance studies related to algorithmic analysis.
No
The device is described as being used for "endoscopic diagnosis" and "observation," not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for endoscopic diagnosis within the upper airway".
No
The device description explicitly states it is a "Rhino-Laryngofiberscope," which is a physical medical device (an endoscope) used for observation. It also mentions accessories and ancillary equipment, including light sources, further indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis within the upper airway". This involves direct visualization of anatomical structures within the body.
- Device Description: The device is a "Rhino-Laryngofiberscope" used for "observation within nasal and nasopharyngeal lumen". This is a tool for direct visual examination.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not process or analyze biological specimens.
The device is clearly an endoscope used for direct visualization in vivo (within the living body), which is not the function of an IVD.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, and other ancillary equipment for endoscpic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, oropharynx, hyporpharynx and larynx.
The Olympus XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment have been designed to be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, hyporpharynx and larynx.
Product codes
EOB
Device Description
This subject device "XENF-DP Rhino-Laryngofiberscope" is used for observation within nasal and nasopharyngeal lumen. This endoscope enables use of 2 types of light sources, a detachable single use battery light source powered and a light cable light source. "XENF-DP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601-1 and IEC60601-2-18. There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal cavity, nasopharynx, oropharynx, hyporpharynx and larynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
510(k) SUMMARY
XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92.
A. Submitter's Name, Address, Phone and Fax Number
1. Manufacturer of the subject device
| Name & Address of Manufacturer; | Olympus Optical Co,. Ltd.
2-3-1 Shinjuku Monolis Nishi-shinjuku
Shinjuku-ku, Tokyo, 163-0914
Japan |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Registration No : | 810047 |
| Address, Phone and Fax Number
of R&D Department
Endoscope Division | 2951 Ishikawa-cho
Hachioji-shi, Tokyo 192-8507
Japan
TEL 81-426-42-5177
FAX 81-426-46-5613 |
2 Name of Contact Person Name :
Address, Phone and Fax
Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631) 844-5688 FAX (631) 844-5416
B. Device Name, Common Name
| 1. Device Name : | XENF-DP Rhino-Laryngofiberscope, its
accessories and ancillary equipment |
|--------------------------|-----------------------------------------------------------------------------|
| 2. Common/Usual Name : | Fiber Scope for Rhino-Laryngofiberscope |
| 3. Classification Name : | 21CFR 876.1500
21CFR 868.5530
21CFR 874.4760 |
1
C. Predicate Devices :
| Model | Device Description &
510(k)#/ Date of Cleared | Manufacturer |
|----------------------------------------------------------|--------------------------------------------------|-------------------------------------|
| Pentax Naso-Pharyngo-
Laryngosocope
FNL-15P2/15RP2 | #K921707
07/01/1992 | Pentax Precision
Instrument Corp |
| LF-TP/DP
Tracheal Intubation Fiberscopes | #K981543
08/06/1998 | Olympus Optical Co., |
| LF-DP
Gastrointestinal and Sigmoid
Fiberscope | #K002231
1/30/2001 | Olympus Optical Co., |
D. Summary Description of the Device
1. Summary
This subject device "XENF-DP Rhino-Laryngofiberscope" is used for observation within nasal and nasopharyngeal lumen. This endoscope enables use of 2 types of light sources, a detachable single use battery light source powered and a light cable light source.
2. Design
"XENF-DP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601-1 and IEC60601-2-18.
3. Materials
There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions.
E. Intended Use of the device
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, and other ancillary equipment for endoscpic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, oropharynx, hyporpharynx and larynx.
F. Technological Characteristics
This endoscope does not have special technological characteristics, when compared to the predicate device.
G. Reason for not requiring clinical data
When compared to the predicate devices, "XENF-DP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Observation within nasal and nasopharyngeal lumen has been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of its safety and efficacy.
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Image /page/2/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized representation of a human face in profile, composed of three curved lines that resemble both a face and a bird in flight. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2001
Olympus Optical Co., Ltd. c/o Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157
Re: K011869
Trade Name: Olympus XENF-DP Rhino-Laryngofiberscope Regulation Number: 21 CFR 874.4760 Regulatory Class: Class II Product Code: EOB Dated: June 11, 2001 Received: June 14, 2001
Dear Ms. Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have forious your car ovice is substantially equivalent (for the indications for use above and we nevelopment to devices marketed in interstate commerce prior to May 28, 1976, the suace in the enother) Device Amendments, or to devices that have been reclassified in encentions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the providers subject to the general controls provisions of the Act. The general cherols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (I remarket I Ipproval), it ina), be our of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may occinery "firm announcements concerning your device in the Federal Register. Please note: publish farther unitounteen notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Laura Storms-Tyler
This letter will allow you to begin marketing your device as described in your 510(k) premarker notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in bold, black letters. There are two black lines underneath the word. The lines are of different lengths, with the top line being shorter than the bottom line.
Indications for Use Statement
510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________
Device Name: XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment.
Indications for Use:
The Olympus XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment have been designed to be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, hyporpharynx and larynx.
J. Santos
Division Sign-Off Division of Ophthalmic Devic KO1186 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ OR
(Prescription 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)